Possible Glass Particle Contamination Prompts HPV Vaccine Recall

One Lot of Gardasil Involved, Says Merck

Merck & Co. Inc. recently informed the CDC(www.cdc.gov) that the company is recalling one lot of its quadrivalent human papillomavirus (HPV) vaccine Gardasil because some of the vials may be contaminated with minute glass particles resulting from breakage during the manufacturing process.

In a prepared statement(www.cdc.gov), the agency said of the 743,360 vials included in the recall, as many as 10 may contain the particles. Vaccine from the affected lot -- No. J007354 -- was distributed between Aug. 20 and Oct. 9.

No adverse events related to immunizations administered using vials from this lot of HPV vaccine have been reported other than the usual types of mild reactions that can result from any vaccination (i.e., redness, soreness at the injection site). The effectiveness of the vaccine is not affected by the problem, and any patient who received vaccine from this lot does not need to be revaccinated.

As always, clinicians should report adverse events associated with vaccine administration to the Vaccine Adverse Event Reporting System, a national vaccine safety surveillance program co-sponsored by the CDC and the FDA.

"This recall was caused by an isolated problem in the vaccine manufacturing process," the CDC statement noted. "HPV vaccine continues to have a strong safety record(www.cdc.gov), and CDC continues to recommend that all preteen girls and boys receive three doses of the vaccine at age 11 or 12 years."

According to a Dec. 20 announcement(www.merckvaccines.com) from Merck, the company currently is contacting physician offices and clinics that received vaccine from this lot to instruct them how they may return any unused product. Physicians who received affected vaccine via a third-party distributor will be contacted by that source. Questions about the recalled product, including how to return it and how to get reimbursed for returned product, may be directed to Stericycle Inc. at (855) 741-4996.

In its release, Merck stressed that the company has adequate inventory to replace recalled product at this time, and this voluntary recall does not affect the overall supply of quadrivalent HPV vaccine.